The present invention relates to pharmaceutical compositions containing an inhibitor of gastrointestinal lipase, and at least one compound selected from the group consisting of psyllium husk, its derivatives and salts thereof.
Psyllium husk, has a long history of use in traditional and herbal medicine and has been in use in the United States over 60 years ago. Psyllium husk is derived from the seed or leaves of the Plantago ovata plant. Besides Plantago ovata, psyllium is also known as Ispaghula and Ispagol. Plantago ovata is an annual herb native to Asia, the Mediterranean region, and North Africa. Psyllium grows in sand and silty soils. Currently, psyllium is extensively cultivated in India and Pakistan. India provides about 85% of the psyllium available in the world market. The US is the world's largest importer of psyllium husk. Psyllium has a long history of use through the world and has been used in traditional medicine in the United States, Europe, India, and China. Some of the uses of psyllium in traditional medicine are as laxative, emollient, demulcent, and diuretic.
Currently in the United States, psyllium husk is most often used as a bulk fiber laxative, in foods or in various fiber supplements. In 1998, the Food and Drug Administration (FDA) authorized the use in a health claim in the labeling of foods and dietary supplements containing psyllium husk. The health claim may state that diets low in saturated fat and cholesterol that include 7 grams of soluble fiber per day from psyllium may reduce the risk of heart disease by lowering cholesterol levels in the blood.
Psyllium is a bulk forming fiber. Other fibers that belong to the class of bulk forming fibers are cellulose, methylcellulose, sodium carboxymethylcellulose, karaya, malt soup extract, polycarbophil, and wheat bran. Bulk forming fibers are laxatives because of their water holding properties. They exert their action primarily through mechanical effects by bulking the colonic contents and shortening transit time.
Anal leakage of oil (oily spotting) is an adverse effect which is occasionally observed in patients treated with lipase inhibitors. It results from physical separation of some liquid unabsorbed dietary fat from the bulk of the fecal mass in the lower large intestine.